Inverting the Enrollment Trend of Clinical Trials One of the largest challenges facing the industry today is inverting the trend of clinical trials failing to complete enrollment on time. Raising awareness of a particular clinical trial with call-to-action advertising, such as broadcast television or radio, is one approach among many available to meet that challenge. Such advertising efforts, however, present challenges of their own that must be addressed. The Challenges of Effectively Handling Large Response Volume Television or radio advertising can effectively raise awareness of a clinical-research trial at a reasonable cost. In turn, properly managing the responses from this type of advertising becomes the next challenge. Effective management of responses requires not just handling the responses, but handling them in a timely way that encourages enrollment. Providing a poor experience at the recruiting phase is a sure way to lose a potential participant. Effective management also requires metric gathering methodologies that capture the right data without undue cost or interference with the study. With the timely delivery of the right data, corrective action can be taken fast enough to keep the trial on its timeline. Response Handling Topologies Designing the clinical study to receive responses from a Website, in addition to telephone call responses, can be an effective measure for properly handling responses. A Website will decrease response load at peak telephone hours. To be an effective management tool for responses, however, the Website must do more than just divert responders from calling; it must also encourage participation and screen the responders. Deploying a centralized advertising campaign does not necessarily mean routing telephone call responses to a call center. Making the choice between routing telephone call responses to the investigator or to a call center is the next major consideration in properly managing responses. This decision should be made carefully and should be based upon a cost-benefit analysis. The cost side of the equation should be based upon a realistic estimate of the number of operators and the line capacity required to handle peak telephone call volume throughout the advertising campaign. Many investigators prefer to receive their own telephone call responses, and many have adequate staff to handle large telephone call volume. Others would prefer not to receive their own calls. Even well-staffed investigators may become frustrated and defer taking calls if the advertising draws a high percentage of unqualified responders. When there is a desire to route calls to the site and the potential rate of unqualified responders is high, techniques to reduce that rate should be considered, such as a prescreening IVRS. Managing the Tactics Properly managing the call center depends upon receiving the usual call-center metrics and acting upon that information when necessary. In addition, care should be taken to obtain all telephone call attempts sent to the call center so that busy and non-answered calls can be measured. All metrics should be obtained and analyzed at the beginning of the advertising campaign to ensure that any problems are caught and corrected right away. Delivery of Website and telephone call referrals is typically done by fax, but faxing referrals can be problematic at the clinic. The information is often intentionally sent piecemeal for confidentiality reasons, and referrals can get lost among other office faxes or referrals from other studies. Managing this process manually requires following up with the investigator to ensure receipt and refaxing as necessary. This process is disruptive to the investigator and is costly to the sponsor. Nonetheless, a manual or technological solution for delivering and managing referrals must be considered if broadcast advertising is to be effectively deployed. Tracking and Technology Tracking responses from broadcast advertising includes tracking not just the response count by market, but also obtaining as much granularity of detail as possible on the counts. This serves as a way to measure market-by-market performance, ineffective placement tactics, and effectiveness of the handling of responses. Tracking the investigator’s response and referral activity is a necessary part of effective management when using broadcast advertising. Again, when performed manually, this process can be slow, inaccurate, and taxing for the investigator. Using the latest technologies to assist in managing high-response volume allows study managers to make the most of their broadcast advertising, while increasing efficiency and reliability and decreasing cost. In turn, this will result in more trials being completed on time. Lance Nickens, President Using the latest technologies to assist in managing high-response volume allows study managers to make the most of their broadcast advertising, while increasing efficiency and reliability and decreasing cost. One of the largest challenges facing the industry today is inverting the trend of clinical trials failing to complete enrollment on time. Raising awareness of a particular clinical trial with call-to-action advertising, such as broadcast television or radio, is one approach among many available to meet that challenge. Such advertising efforts, however, present challenges of their own that must be addressed. The Challenges of Effectively Handling Large Response Volume Television or radio advertising can effectively raise awareness of a clinical-research trial at a reasonable cost. In turn, properly managing the responses from this type of advertising becomes the next challenge. Effective management of responses requires not just handling the responses, but handling them in a timely way that encourages enrollment. Providing a poor experience at the recruiting phase is a sure way to lose a potential participant. Effective management also requires metric gathering methodologies that capture the right data without undue cost or interference with the study. With the timely delivery of the right data, corrective action can be taken fast enough to keep the trial on its timeline. Response Handling Topologies Designing the clinical study to receive responses from a Website, in addition to telephone call responses, can be an effective measure for properly handling responses. A Website will decrease response load at peak telephone hours. To be an effective management tool for responses, however, the Website must do more than just divert responders from calling; it must also encourage participation and screen the responders. Deploying a centralized advertising campaign does not necessarily mean routing telephone call responses to a call center. Making the choice between routing telephone call responses to the investigator or to a call center is the next major consideration in properly managing responses. This decision should be made carefully and should be based upon a cost-benefit analysis. The cost side of the equation should be based upon a realistic estimate of the number of operators and the line capacity required to handle peak telephone call volume throughout the advertising campaign. Many investigators prefer to receive their own telephone call responses, and many have adequate staff to handle large telephone call volume. Others would prefer not to receive their own calls. Even well-staffed investigators may become frustrated and defer taking calls if the advertising draws a high percentage of unqualified responders. When there is a desire to route calls to the site and the potential rate of unqualified responders is high, techniques to reduce that rate should be considered, such as a prescreening IVRS. Managing the Tactics Properly managing the call center depends upon receiving the usual call-center metrics and acting upon that information when necessary. In addition, care should be taken to obtain all telephone call attempts sent to the call center so that busy and non-answered calls can be measured. All metrics should be obtained and analyzed at the beginning of the advertising campaign to ensure that any problems are caught and corrected right away. Delivery of Website and telephone call referrals is typically done by fax, but faxing referrals can be problematic at the clinic. The information is often intentionally sent piecemeal for confidentiality reasons, and referrals can get lost among other office faxes or referrals from other studies. Managing this process manually requires following up with the investigator to ensure receipt and refaxing as necessary. This process is disruptive to the investigator and is costly to the sponsor. Nonetheless, a manual or technological solution for delivering and managing referrals must be considered if broadcast advertising is to be effectively deployed. Tracking and Technology Tracking responses from broadcast advertising includes tracking not just the response count by market, but also obtaining as much granularity of detail as possible on the counts. This serves as a way to measure market-by-market performance, ineffective placement tactics, and effectiveness of the handling of responses. Tracking the investigator’s response and referral activity is a necessary part of effective management when using broadcast advertising. Again, when performed manually, this process can be slow, inaccurate, and taxing for the investigator. Using the latest technologies to assist in managing high-response volume allows study managers to make the most of their broadcast advertising, while increasing efficiency and reliability and decreasing cost. In turn, this will result in more trials being completed on time. n The Patient Recruiting Agency, Austin, Texas, specializes in the production and placement of customized direct-to-patient advertising and technological support solutions specifically for sponsors, CROs, SMOs, and investigators. For more information, visit patientrecruiting.com. June 2007 VIEW on Clinical Services

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